The authors of a recent journal article see problems with the FDA’s approach to premarket review of artificial intelligence (AI) algorithms, including an undue reliance on single-site algorithm development. Regulatory attorney Brad Thompson told BioWorld, however, that hospital administrators want algorithms that maximize accuracy for their populations and are not averse to in-house development of just such an algorithm, thus creating a source of tension between what hospitals want and what the FDA expects.
The COVID-19 pandemic has affected wide swaths of the global economy, mostly in a negative manner, but it has spurred some types of innovation at a rate that would be unimaginable in ordinary times. That seems to be the take-away for an emergency use authorization (EUA) granted to Miami-based Tiger Tech Solutions Inc. for its COVID Plus monitor, which uses plethysmography and a machine learning algorithm to provide a screening mechanism at mass gatherings, thus bringing the world one step closer to a state of normalcy.
MIT Media Labs spinoff Empatica Inc. secured the CE mark for its Aura system, a wearable solution for the monitoring and early alert of respiratory infections, including COVID-19. For use with people 14 and older, Aura is commercially available in Europe and the U.K., and for pilot purposes in the U.S. – pending FDA authorization. Aura’s algorithm analyzes vital signs from Empatica smartwatches, comparing data against the wearer’s historical baselines. In validation studies, Aura was able to detect patients with possible H1N1 influenza, rhinovirus or SARS-CoV-2 infection with 0.94 sensitivity. Detection occurred on average two days after infection.
The U.S. FDA cleared Alivecor Inc.'s Kardia AI V2 interpretive electrocardiogram (ECG) algorithm for use in its personal ECG app and devices. Currently, the Kardia line permits consumers to take a 30-second medical grade ECG at home and instantly see whether they are exhibiting symptoms of atrial fibrillation, bradycardia, tachycardia or have normal heart rhythm.
Med-tech IPOs continue to make it out onto a strong stock market, even as global economic uncertainty prevails amidst the unfolding pandemic. Single-cell biology research company Berkeley Lights Inc. priced an upsized IPO to raise $178.2 million to back its tools that are used to help develop antibody therapeutics, cell therapies and, more broadly, synthetic biology products.
Machine learning-based diagnostics startup Dascena Inc. has won the U.S. FDA’s breakthrough device designation for its Previse algorithm, which is designed to predict acute kidney injury (AKI) before clinical symptoms. In early validation tests, Previse detected AKI more than a day before patients exhibited kidney damage or impaired function.
LONDON – Owkin Inc. added a further $18 million to its series A, bringing the amount raised in the round to $70 million and equipping the company to push forward with its federated learning approach to applying artificial intelligence (AI) to the analysis of health data.
Evidation Health Inc. reported good news this week in the form of the close of $45 million in series D funding, with an eye toward the expansion of its research platform, Achievement, to include virtual health. B Capital Group led the round, with Mckesson Ventures and Section 32 joining, in addition to existing investors Revelation Partners, Rethink Impact and SV Health Investors.
Researchers working as part of the Quantitative Imaging Biomarkers Alliance (QIBA) have recently validated an open-source algorithm that can be used to measure blood flow using existing 3D ultrasound technology from major manufacturers. They published their results in the June 30, 2020, issue of Radiology.
Startup Brightinsight Inc. is working to make the infrastructure behind digital health easily accessible to pharma and med-tech companies. To aid it on this path, the San Jose, Calif.-based company has raised a $40 million series B round to expand its capabilities and global reach.
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